Diabetic Foot Clinical Trial
Official title:
A Randomized, Controlled, Parallel Design, Safety and Efficacy Study of Granulocyte Colony Stimulating Factor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy in Subjects With Diabetic Limb Ischemia.
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
One devastating complication of diabetes is peripheral arterial disease (PAD) including
critical limb ischemia (CLI), which may result in limb loss. Epidemiological evidence
confirms an association between diabetes and increased prevalence of peripheral arterial
disease (PAD). The prevalence of peripheral vascular disease among the Indian diabetic
population is 13%.
This therapy provides a targeted approach i.e. by improving blood perfusion in the ischemic
area of the lower limb by inducing neovascularization, which would be further evaluated by
measuring the change in transcutaneous partial pressure of oxygen (TCpO2), NMR angiography
of local vessels, ulcer healing, pain relief, limb salvage, ABI index etc.
The specific design of the trial enables us to differentially study the effect of stem cell
on diabetic foot CLI as compared to G-CSF (granulocyte colony stimulating factor) in (one
control group) and standard therapy (in another control group), this study would also
evaluate the effect of stem cell dose.
Extracting stem cells from this method is far more easy to perform as compared to extracting
from bone marrow and is less painful for the patient as well.
The yield of mononuclear stem cell from peripheral blood is much higher as compared to bone
marrow and role of CD34+ cells in limb ischemia is not yet established in humans, therefore
this study would evaluate the dynamics of different types of mononuclear cells and its
correlation with the therapeutic effect.
This clinical trial highlights the safety of using G-CSF in diabetic CLI by having a
separate control group in which volunteers would be given only G-CSF through subcutaneous
route, also this would tell about the therapeutic effect if any attributable to it.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06154915 -
Immune Cells in Diabetic Chronic Foot Ulcers
|
||
Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT02373592 -
Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
|
N/A | |
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Completed |
NCT01212120 -
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
|
N/A | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Recruiting |
NCT04085705 -
The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
|
||
Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
Completed |
NCT04480801 -
The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer
|
N/A | |
Not yet recruiting |
NCT04537676 -
Patient Empowerment Study
|
||
Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A | |
Recruiting |
NCT05974592 -
The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
|
N/A | |
Not yet recruiting |
NCT04630795 -
ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
|
||
Not yet recruiting |
NCT05431660 -
Diabetic Foot School and Biomechanics
|
N/A | |
Completed |
NCT05101473 -
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
|
N/A | |
Completed |
NCT05123157 -
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
|
||
Enrolling by invitation |
NCT05043636 -
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
|
||
Completed |
NCT03254095 -
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
|